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NCT Number: NCT06499623

Early Detection of Malnutrition in Oncology Patients and Elderly Patients

The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic.

The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital, Brno, Czechia

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About this study

The main goal of the project is the early detection of malnutrition in oncology patients and hospitalised patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

Another goal of the project will be the creation of a unified diagnostic proposal process and methodological material for determining malnutrition. This process will then be designed as the standard of nursing practice for patients with an oncological diagnosis and for persons older than 65 years such that, so that an adequate nutritional intervention is started in time, which will lead to a higher tolerance of demanding treatment and thus to increase the quality of life.

The project will include testing the procedure on a sample of approx. 1,500 oncological and 500 geriatric patients.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000282.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort Oncological patients:

  • 18+
  • an oncological diagnosis
  • a survival prognosis of at least 3 months

Cohort Patients older than 65 years:

  • 65+
  • hospitalization at least 14 days or longer

Exclusion criteria

(both cohorts):

  • not agreeing to participate in the project

Treatment and study plan

Blood test

Diagnostic Test

Albumin, C-Reactive Protein, Cholesterol, Urea, Creatinine, Vitamin D

Bioelectrical Impedance Analysis

Diagnostic Test

Total Impedance, Segmental Muscle Analysis, Segmental Fat Analysis, Absolute Muscle Mass Value, Muscle Mass Index, Total Body Fat Percentage, Total Body Water, Phase Angle Measurement

Nutritional Risk Assessment Questionnaire

Other

Fill in the Questionnaire of the Working Group on Nutritional Care in Oncology and get nutrition risk score. The objective data includes weight loss in 6 months, current BMI and food tolerance, and oncological diagnosis including ongoing anti-cancer treatment.

Primary outcomes

  1. Number of people with malnutrition according to the PSNPO questionnaire

    Time frame: Until 31. 3. 2026

Secondary outcomes

  1. Proportion of people with initiated nutritional intervention

    Time frame: Until 31. 3. 2026

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Mandelova, PhD

CONTACT

[email protected]

+420 770 190 828

Nikola Stourac

CONTACT

[email protected]

+420 739 012 354

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • Brno University Hospital
  • Bulovka Hospital
  • General University Hospital, Prague
  • Hospital AGEL Nový Jičín a.s.
  • Masaryk Memorial Cancer Institute
  • Military University Hospital, Prague
  • University Hospital Olomouc
  • University Hospital Pilsen
  • University Hospital, Motol

Registry information

Official study title

Early Detection of Malnutrition in Oncology Patients and People Over 65 Years of Age

Acronym: MALNUTRITION

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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